At a glance
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Randomized Double-blind Placebo-controlled Trial Assessing the Efficacy of Standard and Low Dose Hydrochlorothiazide Treatment in the Prevention of Recurrent Nephrolithiasis
In Brief
A Phase 3 clinical trial evaluating Placebo oral capsule, 12.5 mg hydrochlorothiazide, and 2 other interventions for Nephrolithiasis. Completed, enrolled 416 participants across 12 sites.
Detailed Summary
The investigators plan to assess the efficacy of standard and low dose HCTZ treatment in the recurrence prevention of calcium-containing kidney stones. More specifically, the investigators aim to assess the dose-response relationship for three different dosages of HCTZ. Study intervention: HCTZ 12.5 mg, 25 mg or 50 mg once daily per os for 24 or 36 months. In addition, all patients in HCTZ treatment arms will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines. Control intervention: Placebo once daily per os for 24 to 36 months. In addition, all patients in the placebo arm will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines.
Study Details
Timeline
Interventions
Once daily for 3 years
Once daily for 3 years
Once daily for 3 years
Once daily for 3 years